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|Fosamax Plus D

Fosamax Plus D

Fosamax Plus D is used for:

Treating thinning of the bones (osteoporosis) in women following menopause. It may also be used for other conditions as determined by your doctor.

Fosamax Plus D is a bisphosphonate and vitamin D combination. It works by slowing bone breakdown and allowing new bone to be formed. It also helps maintain adequate levels of vitamin D in the body. Vitamin D is needed for bone formation.

Do NOT use Fosamax Plus D if:

• you are allergic to any ingredient in Fosamax Plus D
• you have trouble swallowing or you have a narrow or blocked esophagus
• you have high or low levels of calcium or high levels of vitamin D in your blood
• you have severe kidney problems
• you cannot stand or sit upright for at least 30 minutes

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fosamax Plus D :

Some medical conditions may interact with Fosamax Plus D . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have hardening of the arteries, heart problems, esophagus or throat problems (eg, heartburn), kidney problems, stomach or bowel problems (eg, ulcer, inflammation, food absorption problems), cancer, sarcoidosis, high phosphate levels in the blood, low blood vitamin D levels, or tightness in the chest or chest pain

Some MEDICINES MAY INTERACT with Fosamax Plus D . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of side effects, such as severe heartburn or other esophagus problems, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fosamax Plus D may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fosamax Plus D :

Use Fosamax Plus D as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Fosamax Plus D . Talk to your pharmacist if you have questions about this information.
• Fosamax Plus D is effective only if taken on an empty stomach.
• Swallow Fosamax Plus D whole. Do not break, crush, or chew before swallowing.
• Taking Fosamax Plus D at the same time each week will help you remember to take it.
• Take Fosamax Plus D by mouth with 6 to 8 ounces (180 to 240 mL) of plain water the first thing in the morning, at least 30 minutes before eating, drinking, or taking any other medicine. Do not take Fosamax Plus D with mineral water, coffee or tea, or juice.
• Do not lie down for at least 30 minutes after taking Fosamax Plus D and you have had your first meal or snack of the day.
• Do not take Fosamax Plus D at bedtime or before getting out of bed.
• Calcium or iron supplements, vitamins, or antacids containing calcium, magnesium, or aluminum may interfere with the absorption of Fosamax Plus D . These medicines must be taken at least 2 hours after taking alendronate/cholecalciferol.
• If you miss a dose of Fosamax Plus D , take it on the morning after you remember. Do not take 2 tablets on the same day. Continue your usual schedule of 1 tablet once a week on your chosen day.

Ask your health care provider any questions you may have about how to use Fosamax Plus D .

Important safety information:

• Do not drink alcohol, smoke, or use other tobacco products while taking Fosamax Plus D .
• It is important to have enough calcium and vitamin D in your diet. Ask your doctor or pharmacist if you have questions about your diet or about taking dietary supplements such as calcium or vitamin D.
• Nondrug therapy may also help prevent bone loss. Consult your doctor about a weight-bearing exercise plan or other lifestyle changes that may be helpful. Follow all diet recommendations for adequate daily calcium and vitamin D intake.
• Fosamax Plus D may cause jaw bone problems in some patients. You may be at higher risk if you have cancer, poor dental hygiene, certain other conditions (eg, anemia, blood clotting problems, infection, dental problems), or are using certain medicines or therapies (eg, chemotherapy, corticosteroids, radiation). These problems have often been associated with dental procedures. Talk to your doctor about an appropriate dental examination before you begin treatment with Fosamax Plus D . Certain dental procedures should be avoided if possible while you are using Fosamax Plus D . Ask your doctor any questions you may have about dental treatment while you are using Fosamax Plus D .
• Lab tests, including vitamin D levels and bone density tests, may be performed while you use Fosamax Plus D . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Fosamax Plus D should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fosamax Plus D while you are pregnant. It is not known if Fosamax Plus D is found in breast milk. If you are or will be breast-feeding while you use Fosamax Plus D , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Fosamax Plus D :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloating; bone, muscle, or joint pain; constipation; diarrhea; gas; headache; mild flu-like symptoms (eg, chills, fever, sore throat); nausea; stomach pain; taste change; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; bloody vomit; chest pain; coughing up blood; difficulty swallowing; new, worsening, or severe heartburn; pain upon swallowing; severe bone, joint, or muscle pain; stomach pain.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include black or bloody stools; pain upon swallowing; severe heartburn; stomach pain; ulcers; unusual tiredness or weakness.

Store Fosamax Plus D between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Store in the original blister package or bottle until time of use. Do not store in the bathroom. Keep Fosamax Plus D out of the reach of children and away from pets.

General information:

• If you have any questions about Fosamax Plus D , please talk with your doctor, pharmacist, or other health care provider.
• Fosamax Plus D is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Fosamax Plus D . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.